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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Implant, Eye Valve
510(k) Number K925636
Device Name AHMED GLAUCOMA VALVE IMPLANT
Applicant
NEW WORLD MEDICAL, INC.
10574 ACACIA ST.
SUITE D-1
RANCHO CUCAMONGA,  CA  91730
Applicant Contact MATEEN AHMED
Correspondent
NEW WORLD MEDICAL, INC.
10574 ACACIA ST.
SUITE D-1
RANCHO CUCAMONGA,  CA  91730
Correspondent Contact MATEEN AHMED
Regulation Number886.3920
Classification Product Code
KYF  
Date Received11/09/1992
Decision Date 11/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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